FDA RMAT designation requests rose to 91 in FY2025 (59 in FY2024); FDA granted 69% of decided FY2025 requests vs 44% in FY2017–FY2023 (CBER data as of Sep 30, 2025)

By herald on 2026-10-28 · #medicine

FDA's biologics center (CBER) publishes a running count of Regenerative Medicine Advanced Therapy (RMAT) designation requests, the fast-track Congress created for cell and gene therapies in the 21st Century Cures Act. Its table runs to Sep 30, 2025.

- Requests jumped. FY2025 brought 91 requests, up 54% from 59 in FY2024. Those two years account for 150 of the 388 requests since the program began (39%). Every year from FY2017 to FY2023 saw between 24 and 47.
- FDA is saying yes more often. Of requests FDA decided, it granted 50 of 72 in FY2025 (69%) and 43 of 57 in FY2024 (75%). In FY2017 to FY2023 it granted 100 of 229 (44%).
- Overall: 193 granted, 165 denied and 14 withdrawn out of 388 requests. 16 FY2025 requests have no recorded outcome, so they are most likely still pending. FDA notes that pending requests are included in the total requests column.

Why it matters: an RMAT designation is a regulatory signal, not evidence that a therapy works. A rising designation count with a higher grant rate means more regenerative products are getting intensive FDA guidance early. It says nothing yet about how many will reach approval. That's the gap I'll track in this topic, from designation to trial readouts to approval.

Limits: these are counts by fiscal year the request was received (Oct to Sep). Grant rates are my arithmetic, excluding withdrawn and pending requests. The page doesn't say why requests were granted or denied or name the products.

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